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Low Dose Euthyrox in Treatments of Paraquat Intoxication.

Low Dose Euthyrox in Treatments of Paraquat Intoxication: a Randomized, Controlled, Multicenter Trial in China.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04132622
Acronym
LDETPI
Enrollment
80
Registered
2019-10-21
Start date
2020-01-01
Completion date
2023-12-31
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraquat Poisoning

Keywords

Euthyrox, Paraquat Intoxication

Brief summary

Paraquat is a common human toxicant and accounts for 20 deaths per million persons in the world. Paraquat usually cause multiple organ dysfunction syndrome, including liver, kidney, lung and heart dysfunction. Besides, pituitary insufficiency also occurs on those patients with paraquat poisoning, which leads to multiple endocrine gland dysfunction, involving adrenal gland, thyroid and sex gland. As a result, the investigators decide to initiate the clinical trial to find whether thyroid replacement therapy can furtherly reduce the mortality, and improve patients long-term prognosis.

Detailed description

Paraquat is a common human toxicant and accounts for 20 deaths per million persons in the world. Its accidental or deliberate ingestion is associated with a high mortality rate ranging from 40% to 70%. Paraquat usually cause multiple organ dysfunction syndrome, including liver, kidney, lung and heart dysfunction. Besides, pituitary insufficiency also occurs on those patients with paraquat poisoning, which leads to multiple endocrine gland dysfunction, involving adrenal gland, thyroid and sex gland. Nowadays, steroids, as a hormone replacement therapy, is one of most important drugs for paraquat poisoning, and it has decreased patients' mortality greatly since using it. However, the clinicians have not paid enough attention to thyroid replacement therapy, as thyroid dysfunction is also the key pathophysiological course when paraquat poisoning occurs. As a result, the investigators decide to initiate the clinical trial to find whether thyroid replacement therapy can furtherly reduce the mortality, and improve patients long-term prognosis.

Interventions

Levothyroxine Sodium Tablets (50 ug, calculated by Levothyroxine Sodium ), produced by Merck KGaA, Darmstadt.

DRUGTraditional therapy

including steroids, vitamin C, hemodialysis and blood perfusion.

Sponsors

First People's Hospital of Hangzhou
CollaboratorOTHER
Zhejiang Provincial Hospital of TCM
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* all the patients who are diagnosed by paraquat poisoning

Exclusion criteria

* patients who can not cooperate with the trial; patients who would not like to join in the trial.

Design outcomes

Primary

MeasureTime frameDescription
Rate of death weeklya weekRate of death in a week.
Rate of death monthlya monthRate of death in a month.
Rate of death yearlya yearRate of death in a year.
Survival rate yearlya yearSurvival rate in a year.

Secondary

MeasureTime frameDescription
Number of Participants with Kidney dysfunctiona week, a month, a yearNumber of Participants with Kidney dysfunction with paraquat poisoning

Contacts

Primary ContactYuemei Chen, doctor
324347@zju.edu.cn+86 18758120192
Backup ContactXiu Yang, master
+86 13732221703

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026